Job Title: Clinical Operations Manager
Department: Country Management
Reporting to: Regional Manager/Regional Director
Location: Home Based Belgium/Netherlands
Travel: >40% Nationally / Internationally
The “FSP (Functional Service Provider) Partner Line Manager” will be responsible and accountable for the direct oversight of Clintec FSP resources within the Country / Region. The Line Manager will be the main point of contact for assigned staff members in the region as the direct reporting line and will provide supervision, support, guidance, mentoring, coaching and counselling to those team members on a day to day basis.
The “FSP Partner Line Manager” will also be the primary local point of contact for Clintec’s FSP Client(s) within the country(ies) and will be involved in day to day interaction with the client’s designated representative(s) in all matters related to resourcing, assignment of personnel, employee performance and deliverables.
Client Relationship Management
Dedicated local point of contact for all client operational, business performance and employee performance related matters.
Represent Clintec at local and regional client meetings.
Consult with client to understand local business needs and objectives.
Manage effective action, escalation and resolution of client raised issues.
Support Clintec’s Global Client Relationship Management strategy and provides timely updates and responses to the CRM team.
Adhere to the Global Client Communication Strategy and Lines of Communication, as agreed with the client.
Individual Line Management
Conduct employee monthly one to ones, end of probation reviews and annual appraisals aligned to the global Performance Management SOP; set, develop and review objectives accordingly.
Oversee team member performance by maintaining daily contact with direct reports to understand workload, activity and performance against requirements and objectives.
Follow up with individual staff members on the status and timeliness of deliverables – e.g. planned / completed monitoring visits, monitoring visit reports, timecard reporting and other items as required.
Inspect and review deliverable items, e.g. monitoring visit reports, to assess quality and provide guidance and feedback in line with QC plan.
Provide guidance or orchestrate training where necessary on practical aspects of clinical trial monitoring, ICH-GCP, time management and general processes.
Accompany CRA’s to site to observe and assess performance and provide constructive feedback, coaching and orchestrate remedial training as may be required; report and document assessment according to SOP.
Support resolution of employee issues by providing information and seeking required advice in a timely manner.
Address employee performance issues by implementing performance improvement plans, or initiating investigation and / or disciplinary procedures where warranted.
Oversee and review the completion of ongoing Clintec and client required training of team members to assure compliance to role required training matrices.
In partnership with employee develop individual employee training plans, objectives and succession plans aligned to career aspirations.
Manage all leave administration processes and travel approvals in line with applicable policies.
Support employee offboarding activities to assure completion of tasks and handover of equipment on completion of assignment or exit from company.
Resourcing and Onboarding
Proactively identify key talent within the external market by means of local networking, identifying advertising sources, establishing and maintaining relationships within local industry groups, universities etc.
Support the global resourcing process by conducting clinically biased interviews to assess experience, skill level and suitability aligned to role and client requirements and make recommendations accordingly.
Support the offer management process, including negotiation of contractual terms.
Propose to client qualified, fit for purpose, personnel aligned to role requirements.
Support new employee onboarding including induction, distribution of company equipment, explain Clintec employee process and procedures.
Support new assignee onboarding including stewardship and oversight of client required training processes to assure all required trainings are undertaken, followed and completed within the required timeframe.
Assure timely dissemination of key Clintec and client business messages to team members.
Organise team building sessions, group meetings, trainings and other events as necessary to promote a positive working culture and promote employee motivation.
Support Clintec global communication strategy by providing regular reports and updates to management and participation in management meetings as required.
Complete required Clintec and client systems and process trainings and assure understanding of all relevant key processes for self and team.
Other tasks where required or instructed by management.
Bachelor’s Degree in Life Sciences, Medicine or Nursing or equivalent qualification / experience.
Knowledgeable about the drug development process, ICH-GCP and Local Regulatory Processes
Expert in clinical trial monitoring with recent practical hands on experience and the proven ability to coach, mentor and motivate others in this discipline.
Excellent communication skills including the ability to interact with clients and team members at all levels.
Good presentation skills in keeping with Clintec corporate image.
Ability to proactively identify issues and risks, and put in place mitigation and improvement measures where needed.
Empathetic individual with the ability to listen sensitively to employee or client issues and offer unprejudiced counsel, guidance and support where necessary.
Basic understanding of employment legislation or general people management.
Previous experience as a Lead CRA or CRA Line Manager.
Management experience within Functional Service Provider business relationship.
High level of commercial awareness and ability to recognise ‘bigger picture’.
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.